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Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
herpes simplex thymidine kinase
ganciclovir
Sponsored by
John Stoddard Cancer Center at Iowa Methodist Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed, refractory or relapsed, ovarian epithelial adenocarcinoma, fallopian tube cancer, or extraovarian peritoneal cancer for which no curative therapy exists Must have tissue available from tumor biopsy to grow tumor cells ex vivo Must have failed standard therapy with both a platinum agent (cisplatin or carboplatin) and paclitaxel Site of disease must be less than 5 cm in greatest diameter Evaluable disease by CT scan, physical exam, or laparoscopy No significant peritoneal fibrosis either from disease or prior surgery Surgical lysis of adhesions allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 2,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8.5 g/dL (without transfusion) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 4 times upper limit of normal (ULN) Alkaline phosphatase no greater than 4 times ULN Hepatitis B surface antigen test required prior to study if transaminases greater than 2.0 times ULN No hepatitis B surface antigen Amylase normal PT and PTT normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No cardiac dysfunction by history and exam No ischemic heart disease that may be considered anesthetic or operative risk Pulmonary: No lung disease that may be considered anesthetic or operative risk Other: HIV negative Not pregnant or nursing No acute viral, bacterial, or fungal infection requiring medication within 14 days prior to study No patient with greater than 2 L of ascites at the time of intraperitoneal infusion No underlying condition that would preclude compliance No allergies to study reagent PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent high dose vitamin regimens

Sites / Locations

  • Human Gene Therapy Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2000
Last Updated
November 5, 2013
Sponsor
John Stoddard Cancer Center at Iowa Methodist Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00005025
Brief Title
Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
Official Title
A Phase II Trial of In Vivo Gene Therapy With the Herpes Simplex Thymidine Kinase for the Treatment of Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Unknown status
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
John Stoddard Cancer Center at Iowa Methodist Medical Center

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Gene therapy may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating women who have refractory or relapsed ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
Detailed Description
OBJECTIVES: Determine the efficacy and safety of in vivo gene therapy with herpes simplex thymidine kinase (HSVtk) vector producer cells (VPC) followed by ganciclovir in women with refractory or relapsed ovarian epithelial adenocarcinoma, fallopian tube cancer, or peritoneal cancer. Determine any development of systemic immunity to this regimen or tumor in these patients. Determine the toxic effects of intraperitoneal HSVtk VPC in these patients. OUTLINE: All patients receive an intraperitoneal catheter prior to infusion. Patients receive herpes simplex thymidine kinase (HSVtk) vector producer cells (VPC) IP over 15-60 minutes on day 0, followed by ganciclovir IV 2 times daily on days 28-41. Treatment repeats for up to 3 courses in patients with stable or responsive disease. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 14-20 patients will be accrued for this study within 18-24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
herpes simplex thymidine kinase
Intervention Type
Drug
Intervention Name(s)
ganciclovir

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed, refractory or relapsed, ovarian epithelial adenocarcinoma, fallopian tube cancer, or extraovarian peritoneal cancer for which no curative therapy exists Must have tissue available from tumor biopsy to grow tumor cells ex vivo Must have failed standard therapy with both a platinum agent (cisplatin or carboplatin) and paclitaxel Site of disease must be less than 5 cm in greatest diameter Evaluable disease by CT scan, physical exam, or laparoscopy No significant peritoneal fibrosis either from disease or prior surgery Surgical lysis of adhesions allowed PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 2,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8.5 g/dL (without transfusion) Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 4 times upper limit of normal (ULN) Alkaline phosphatase no greater than 4 times ULN Hepatitis B surface antigen test required prior to study if transaminases greater than 2.0 times ULN No hepatitis B surface antigen Amylase normal PT and PTT normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No cardiac dysfunction by history and exam No ischemic heart disease that may be considered anesthetic or operative risk Pulmonary: No lung disease that may be considered anesthetic or operative risk Other: HIV negative Not pregnant or nursing No acute viral, bacterial, or fungal infection requiring medication within 14 days prior to study No patient with greater than 2 L of ascites at the time of intraperitoneal infusion No underlying condition that would preclude compliance No allergies to study reagent PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent high dose vitamin regimens
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Joseph Link, MD
Organizational Affiliation
John Stoddard Cancer Center at Iowa Methodist Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Human Gene Therapy Research Institute
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

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